Vivos Inc (RDGL)

[DreDiZzlE]

AMIC is attempting to classify radiogel as a class 2 device which the FDA stated in the denial letter of the last denovo that they dont believe its eligible for the denovo program because of the risk level of radiogel.
Would you like the denial letter posted?

FDA said in that letter
"Nor do we believe your device is of low to moderate risk and thus eligible for denovo."

Fda.gov shows class 2 examples: condoms, wheelchairs, and pregnancy kits.

Fda.gov says examples of class 3 are: injectable and sustains life.

What is radiogel closer to a pregnancy test or an injectable item?